Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Sonia Yoo, Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:
NCT00769145
First received: October 7, 2008
Last updated: July 24, 2012
Last verified: July 2012

October 7, 2008
July 24, 2012
October 2008
August 2011   (final data collection date for primary outcome measure)
The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00769145 on ClinicalTrials.gov Archive Site
This study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally. The effects of ranibizumab on corneal epithelial healing and prevention of recurrent neovascularization will be examined. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

As a secondary objective, this study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Neovascularization
Drug: Ranibizumab
0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
Other Name: Lucentis
Experimental: Ranibizumab
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
Intervention: Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
March 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Patient related considerations
  • All patients of both genders will be considered for enrollment.
  • Disease related considerations
  • Patients meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  • Pregnancy (positive pregnancy test)
  • Women seeking to become pregnant
  • Lactating women
  • Prior enrollment in the study
  • Prior glaucoma surgery in the region of the corneal neovascularization
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00769145
20071015
No
Sonia Yoo, Bascom Palmer Eye Institute
Bascom Palmer Eye Institute
Genentech
Principal Investigator: Sonia Yoo, MD Bascom Palmer Eye Institute
Bascom Palmer Eye Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP